BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712LNAB PRDGM INS BL EN US LN

    MDR report key: 1190057 · Received October 6, 2008

    Report

    Report Number
    2032227-2008-01737
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 27, 2008
    Report Date
    September 27, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE. NO BLOOD GLUCOSE LEVEL WAS PROVIDED AT THE TIME OF THE CALL. CUSTOMER'S FRIEND STATED THAT THE CUSTOMER PASSED OUT AT LEAST TWO TIMES BECAUSE HER BLOOD GLUCOSE WAS LOW. CUSTOMER'S FRIEND STATED THAT HE STARTED HAVING HER TO DRINK A LOT OF CIDER, AND HE CALLED THE PARAMEDICS. CUSTOMER'S FRIEND STATED THAT THE CUSTOMER WAS NOT RESPONDING AND SPACING OUT. THE PARAMEDIC CHECKED THE CUSTOMER'S BLOOD GLUCOSE AND THE BLOOD GLUCOSE WAS HIGH AT THE TIME THEY TOOK HER TO HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712LNAB PRDGM INS BL EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention